Identity
- Trade Name
- Vela FDA UDI
- Generic Name
- Neonatal/adult intensive-care ventilator FDA UDI
- Device Name
- VELA CF,DISS,GRN O2,TYPE K,ENG OVERLAY FDA UDI
- Model / Reference
- 16530-00 FDA UDI
- Description
- VELA CF,DISS,GRN O2,TYPE K,ENG OVERLAY FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10190752186521 FDA UDI
- 510(k) Number
- K103211 FDA UDI
- FDA Product Code
- CBK FDA UDI
- GMDN Term
- Neonatal/adult intensive-care ventilator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5895 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Vela by Vyaire Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K103211 also covers:
- AVEA — VYAIRE MEDICAL, INC.
- AVEA — VYAIRE MEDICAL, INC.
- AVEA — VYAIRE MEDICAL, INC.
- AVEA II — VYAIRE MEDICAL, INC.
- AVEA II — VYAIRE MEDICAL, INC.
- AVEA II — VYAIRE MEDICAL, INC.
- AVEA™ — VYAIRE MEDICAL, INC.
- AVEA™ — VYAIRE MEDICAL, INC.
- AVEA™ — VYAIRE MEDICAL, INC.
- AVEA™ — VYAIRE MEDICAL, INC.
- AVEA™ — VYAIRE MEDICAL, INC.
- AVEA™ — VYAIRE MEDICAL, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Vyaire Medical, Inc.
Sources (1)
- FDA UDI dfafd812-53e4-4854-9e45-3f060118bbd6 35 fields · synced Jun 1, 2026